NCT01521676

Brief Summary

Research of predictive clinical and biological factors in breast cancer : genomic, proteomic, mutation

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
749

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 22, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2025

Enrollment Period

15.1 years

First QC Date

December 22, 2011

Last Update Submit

April 16, 2026

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

  • molecular alteration in breast cancer

    gene expression level

    average of 4 weeks after diagnosis

Secondary Outcomes (1)

  • relation between molecular alteration and clinical and histological characteristics

    up to 3 years

Study Arms (1)

breast cancer

EXPERIMENTAL

blood and tumor sample

Genetic: molecular alteration

Interventions

molecular alterationGENETIC

research of molecular alteration

breast cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • breast cancer
  • age \> 18
  • signed informed consent

You may not qualify if:

  • emergency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Paoli Calmettes

Marseille, 13009, France

Location

Hôpital Sainte-Musse

Toulon, France

Location

Related Publications (5)

  • Fattori S, Le Roy A, Houacine J, Robert L, Abes R, Gorvel L, Granjeaud S, Rouviere MS, Ben Amara A, Boucherit N, Tarpin C, Pakradouni J, Charafe-Jauffret E, Houvenaeghel G, Lambaudie E, Bertucci F, Rochigneux P, Goncalves A, Foussat A, Chretien AS, Olive D. CD25high Effector Regulatory T Cells Hamper Responses to PD-1 Blockade in Triple-Negative Breast Cancer. Cancer Res. 2023 Sep 15;83(18):3026-3044. doi: 10.1158/0008-5472.CAN-23-0613.

    PMID: 37379438RESULT

  • Fattori S, Gorvel L, Granjeaud S, Rochigneux P, Rouviere MS, Ben Amara A, Boucherit N, Paul M, Dauplat MM, Thomassin-Piana J, Paciencia-Gros M, Avenin M, Pakradouni J, Barrou J, Charafe-Jauffret E, Houvenaeghel G, Lambaudie E, Bertucci F, Goncalves A, Tarpin C, Nunes JA, Devillier R, Chretien AS, Olive D. Quantification of Immune Variables from Liquid Biopsy in Breast Cancer Patients Links Vdelta2+ gammadelta T Cell Alterations with Lymph Node Invasion. Cancers (Basel). 2021 Jan 25;13(3):441. doi: 10.3390/cancers13030441.

    PMID: 33503843RESULT

  • Guerin M, Eyraud R, Tsvetkov P, Finetti P, Giraudo A, Tarpin C, Hassin A, Bechlian D, Mamessier E, Pakradouni J, Boher JM, Goncalves A, Devred F, Bertucci F. The plasma nanoDSF denaturation profiles predict the presence of breast cancer. J Transl Med. 2025 Dec 5;24(1):197. doi: 10.1186/s12967-025-07499-8.

    PMID: 41350712RESULT

  • Guerin M, Goncalves A, Toiron Y, Baudelet E, Pophillat M, Granjeaud S, Fourquet P, Jacot W, Tarpin C, Sabatier R, Agavnian E, Finetti P, Adelaide J, Birnbaum D, Ginestier C, Charafe-Jauffret E, Viens P, Bertucci F, Borg JP, Camoin L. Development of parallel reaction monitoring (PRM)-based quantitative proteomics applied to HER2-Positive breast cancer. Oncotarget. 2018 Sep 18;9(73):33762-33777. doi: 10.18632/oncotarget.26031. eCollection 2018 Sep 18.

    PMID: 30333908RESULT

  • Goncalves A, Bertucci F, Guille A, Garnier S, Adelaide J, Carbuccia N, Cabaud O, Finetti P, Brunelle S, Piana G, Tomassin-Piana J, Paciencia M, Lambaudie E, Popovici C, Sabatier R, Tarpin C, Provansal M, Extra JM, Eisinger F, Sobol H, Viens P, Lopez M, Ginestier C, Charafe-Jauffret E, Chaffanet M, Birnbaum D. Targeted NGS, array-CGH, and patient-derived tumor xenografts for precision medicine in advanced breast cancer: a single-center prospective study. Oncotarget. 2016 Nov 29;7(48):79428-79441. doi: 10.18632/oncotarget.12714.

    PMID: 27765906RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carole TARPIN, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2011

First Posted

January 31, 2012

Study Start

December 22, 2010

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

April 21, 2026

Record last verified: 2025-04

Locations

FR(2)